Arthroscopic Trans-osseous Rotator-Cuff Repair Using the Giant-Needle and Grand-Knot Technique.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- American Shoulder and Elbow Surgeons ASES Score
研究概览
简要总结
The purpose of this study is to compare a novel, cost-effective arthroscopic trans-osseous rotator cuff repair technique, known as the 'Grand-Knot' technique, against the standard repair using all-suture anchors. The study evaluates which method provides better functional recovery and structural healing for patients with full-thickness supraspinatus tears. Patients were randomized to receive either the Grand-Knot repair or the standard anchor repair and were followed for a minimum of 2.5 years to assess shoulder function using the ASES score, range of motion, and tendon integrity."
详细描述
"This prospective randomized comparative study was designed to evaluate the clinical and biomechanical effectiveness of an anchorless trans-osseous repair for rotator cuff tears.
Participants: 160 patients (aged 45-75) with full-thickness supraspinatus or posterosuperior tears were enrolled.
Interventions: > 1. Experimental Group: The Grand-Knot technique utilized a 'Giant Needle' to create trans-osseous tunnels, through which sutures were passed and secured using a specialized suture-block (Grand-Knot) on the lateral cortex. 2. Control Group: Standard arthroscopic repair was performed using 2.8 mm all-suture anchors (Y-Knot RC).
Procedure: All surgeries were performed arthroscopically by a single senior surgeon. Postoperative rehabilitation was standardized for both groups.
Outcomes: The primary endpoint was the American Shoulder and Elbow Surgeons (ASES) score at 30 months. Secondary endpoints included the Constant score, objective range of motion (ROM) measured by a goniometer, and structural integrity of the tendon as assessed by postoperative MRI or ultrasound at 6 months. Additionally, the study incorporates biomechanical data comparing the load-to-failure strength of both constructs."
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 45 to 75 years.
- •Diagnosis of full-thickness supraspinatus or posterosuperior rotator-cuff tears.
- •Tears suitable for arthroscopic repair.
- •Confirmation of diagnosis and tear morphology via standardized clinical examination and MRI.
- •Willingness to comply with a 2.5-year follow-up protocol and standardized rehabilitation.
排除标准
- •Partial-thickness tears or isolated subscapularis tears.
- •Advanced fatty infiltration (Fuchs grade 3-4).
- •Rotator cuff arthropathy (Hamada classification > 2).
- •Presence of calcific tendinitis in the affected shoulder.
- •Prior ipsilateral shoulder surgery.
- •General medical contraindications to arthroscopy or general anesthesia.
- •Inability to complete the follow-up or provide informed consent.
研究组 & 干预措施
Grand-Knot Group
Patients undergoing arthroscopic trans-osseous rotator cuff repair using the Grand-Knot suture-block technique.
干预措施: Grand-Knot Technique (Procedure)
Suture Anchor Group
Patients undergoing standard arthroscopic rotator cuff repair using all-suture anchors.
干预措施: All-Suture Anchors (Y-Knot RC) (Device)
结局指标
主要结局
American Shoulder and Elbow Surgeons ASES Score
时间窗: 30 months (2.5 years) postoperatively
The ASES score is a standardized clinician-completed and patient-reported instrument consisting of two sections: pain (50%) and activities of daily living (50%). The total score ranges from 0 to 100, where 100 indicates the best possible shoulder function and 0 indicates the worst.
次要结局
未报告次要终点
研究者
Sherif Hamdy Zawam
Assistant Professor of Orthopedic Surgery
Cairo University